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Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Advice for manufacturers of Class I medical devices for placing products on the UK market
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
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